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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000016827
Receipt No. R000019457
Scientific Title Concomitant portal vein resection in pancreaticoduodenectomy: Does it benefit patients with pancreatic head cancer and portal vein invasion?
Date of disclosure of the study information 2015/04/10
Last modified on 2019/02/14

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Basic information
Public title Concomitant portal vein resection in pancreaticoduodenectomy: Does it benefit patients with pancreatic head cancer and portal vein invasion?
Acronym Concomitant portal vein resection in pancreaticoduodenectomy
Scientific Title Concomitant portal vein resection in pancreaticoduodenectomy: Does it benefit patients with pancreatic head cancer and portal vein invasion?
Scientific Title:Acronym Concomitant portal vein resection in pancreaticoduodenectomy
Region
Japan

Condition
Condition Pancreatic cancer
Classification by specialty
Hepato-biliary-pancreatic surgery
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 We aimed to identify prognostic factors for survival in patients who underwent pancreaticoduodenectomy including concomitant portal vein resection.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Survival benefit of portal vein resection
Key secondary outcomes Morbidity, Mortality

Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Patiens with pancreas cancer who had done radical resection in Hokkaido Univ. Hospital department of surgery II during January 1999 to March 2009.
Key exclusion criteria Cases with exploratory laparotomy
Target sample size 120

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Takehiro Noji
Organization Hokkaodo University Graduate schoolof medicine
Division name Gastroenterological Surgery II
Zip code
Address Kita 15 Nishi 7, Kita-ku, Sapporo city
TEL 011-716-1161
Email drnoji@med.hokudai.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Takehiro Noji
Organization Hokkaodo University Graduate schoolof medicine
Division name Gastroenterological Surgery II
Zip code
Address Kita 15 Nishi 7, Kita-ku, Sapporo city
TEL 011-716-1161
Homepage URL
Email drnoji@med.hokudai.ac.jp

Sponsor
Institute Hokkaodo University Graduate school of Medicine
Institute
Department

Funding Source
Organization Hokkaodi University Graduate school of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 北海道大学病院

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 10 Day

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2014 Year 12 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 03 Month 10 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information 112 patients were included in this retrospective study.

Management information
Registered date
2015 Year 03 Month 17 Day
Last modified on
2019 Year 02 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019457

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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